4 FR SINGLE LUMEN (SL) POWERPICC CATHETER

K070996 · C.R. Bard, Inc. · LJS · May 8, 2007 · General Hospital

Device Facts

• Record ID: K070996
• Device Name: 4 FR SINGLE LUMEN (SL) POWERPICC CATHETER
• Applicant: C.R. Bard, Inc.
• Product Code: LJS · General Hospital
• Decision Date: May 8, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PowerPICC® catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, power injection of contrast media and allows for central venous pressure monitoring. For blood sampling, infusion or therapy, use a 4 French or larger catheter. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.

Device Story

4 Fr SL PowerPICC® is an open-ended, radiopaque polyurethane peripherally inserted central catheter (PICC). Device features reverse taper design, 55 cm usable length, and depth indicators. Purple colorant differentiates it as power-injectable. Used for peripheral access to central venous system for IV therapy, contrast media power injection (max 5ml/sec), and central venous pressure (CVP) monitoring. Operated by clinicians in clinical settings. Provides access for infusion, blood sampling, and pressure monitoring; facilitates clinical decision-making via CVP data and therapy delivery. Benefits include reliable long-term venous access and compatibility with power injection protocols.

Clinical Evidence

No clinical data. Bench testing only. Testing included biocompatibility per ISO 10993, and performance testing per ISO 10555-1 and ISO 10555-3. Additional testing conducted for invasive blood pressure monitoring per IEC 60601-2-34, AAMI TIR9, and ANSI/AAMI BP22. EO sterilization validation performed.

Technological Characteristics

Radiopaque polyurethane catheter; 4 Fr diameter; 55 cm length; reverse taper design. Features depth indicators and purple colorant for identification. Sterilized via ethylene oxide (AAMI/ANSI/ISO 11135). Complies with ISO 10555-1 and ISO 10555-3 standards. Biocompatibility per ISO 10993. No electronic components; passive device.

Indications for Use

Indicated for short or long-term peripheral access to the central venous system for intravenous therapy, power injection of contrast media, and central venous pressure monitoring in patients requiring a 4 French or larger catheter.

Regulatory Classification

Identification

A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.

Special Controls

*Classification.* Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”

Predicate Devices

• 6 Fr TL PowerPICC® Catheter (K053501)
• 5 Fr SL PowerPICC® Catheter (K033389, K051991)

Submission Summary (Full Text)

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K070996

4 Fr SL PowerPICC®

Special 510(k)

#### Section 6

### 510(k) Summary

#### 4 Fr Single Lumen (SL) PowerPICC® Catheter

MAY - 8 2007

## Summary of Safety & Effectiveness Prepared April 23, 2007

| | Submitter of 510(k)<br>Premarket Notification: | Bard Access Systems, Inc. (BAS)<br>[Subsidiary of C.R. Bard, Inc.]<br>Salt Lake City, Utah 84116<br>Phone: [phone], Ext. 7136<br>Fax: [phone] |
|-----------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General<br>Provisions | Contact Person: | Lynn M. Kirchoff<br>Regulatory Affairs Specialist |
| | Device Trade Name: | 4 Fr SL PowerPICC® Catheter |
| | Device Generic Name: | Peripherally Inserted Central Catheter (PICC) |
| | The predicate devices are listed below. | |
| Predicate<br>Devices | Device Name:<br>Trade Name:<br>Common/Usual Name:<br>Classification Name:<br>Premarket Notification: | 6 Fr TL PowerPICC® Catheter<br>PowerPICC® Catheter<br>Peripherally Inserted Central Catheter (PICC)<br>Long Term Intravascular Catheter (80 LJS)<br>K053501, concurrence date-January 13, 2006 |
| | Device Name:<br>Trade Name: | 5 Fr SL PowerPICC® Catheter<br>PowerPICC® Catheter |

PowerPICC® Catheter Common/Usual Name: Peripherally Inserted Central Catheter (PICC) Long Term Intravascular Catheter (80 LJS) Premarket Notification: K033389, concurrence date March 14, 2004 K051991, concurrence date October 20, 2005

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Classification 21 CFR 880.5970, Class II, 80LJS - Long Term Intravascular Catheter Performance Performance standards have not been established by FDA under section 514 of the Standards Federal Food, Drug and Cosmetic Act. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Classification Name:

# 000003

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10000000 2005 4 Fr SL PowerPICC®
Special 510(k)

| Intended Use | The PowerPICC® Catheters are intended for short or long term peripheral access to the<br>central venous system for intravenous therapy and blood sampling. | |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Indications for<br>Use | The PowerPICC® catheter is indicated for short or long term peripheral access to the<br>central venous system for intravenous therapy, power injection of contrast media and<br>allows for central venous pressure monitoring. For blood sampling, infusion or therapy,<br>use a 4 French or larger catheter. The maximum recommended infusion rate is 5ml/sec.<br>For central venous pressure monitoring, it is recommended that catheter lumen of 20<br>gauge or larger be used. | |
| Device<br>Description | The 4 Fr SL PowerPICC® Catheters are open-ended radiopaque polyurethane. Catheter usable length is 55 cm. The catheter has a reverse taper design Catheter shaft tubing is marked with depth indicators, with "0" indicated to<br>serve as a reference for the catheter insertion point. Catheters are provided sterile in basic and full PICC configurations with<br>legally marketed kit components. Purple colorants were added to the catheter materials to provide the catheter<br>with an appearance that allows the end user to differentiate Bard's power<br>injectable catheters from other manufacturers' power injectable catheters. The catheter extension leg, junction and clamp ID tag were printed with<br>markings to identify the catheter as PowerPICC® and to include information to<br>facilitate proper use of the device. | |
| Technological<br>Characteristics | Technological similarities between the subject 4 Fr SL PowerPICC® catheter and the<br>predicate devices remain identical. There are no new questions raised regarding safety<br>or efficacy of the 4 Fr SL PowerPICC®. | |
| Safety and<br>Performance<br>Tests | Biocompatibility requirements of ISO 10993 Biological Evaluation of Medical Devices<br>Part-1: Evaluation and Testing and the FDA Modified ISO 10993 Test Profile for<br>externally communicating, blood contacting, long-term devices were met. All<br>materials used in the manufacture of the subject device were previously cleared for<br>similar applications by Bard Access Systems.<br>Performance testing of the 4 Fr SL PowerPICC® catheter was conducted in accordance<br>with the following FDA guidance documents and international standards: Guidance on Premarket Notification [510(k)] Submission for Short-Term<br>and Long-Term Intravascular Catheters, March 16, 1995 ISO 10555-1:1997, Sterile, Single-Use Intravascular Catheters, General<br>requirements ISO 10555-1:1997, Sterile, Single-Use Intravascular Catheters, General<br>requirements, Amendment 1 ISO 10555-3:1997, Sterile, Single-Use Intravascular Catheters, Central<br>venous catheters AAMI/ANSI/ISO 11135:1994, Medical Devices - Validation and Routine<br>Control of Ethylene Oxide Sterilization | |

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4 Fr SL PowerPIC Special 510(k)

- AAMI/ANSI/ISO 10993-1:2003, Biological Evaluation of Medical . Devices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile
- IEC 60601-2-34: 2000-10, Medical electrical equipment Particular . requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment
- . AAMI TIR9: 1992, Evaluation of Clinical Systems for Invasive Blood Pressure Monitoring
- . ANSI/AAMI BP22: 1994, Blood Pressure Transducers

Subject product testing has yielded acceptable safety & performance outcomes.

In addition, EO sterilization adoption tests also yielded acceptable results. The results of these tests, in conjunction with the substantial equivalence claims as outlined in the premarket notification, effectively demonstrate the 4 Fr SL PowerPICC® catheters' substantial equivalence to the cited predicate devices.

### Summary of Substantial Equivalence

Safety and

Performance

Tests Continued

Based on the indications for use, technological characteristics, and safety and performance testing, the subject 4 Fr SL PowerPICC® catheter meets the minimum requirements that are considered adequate for its intended use and is substantially equivalent in design, materials, sterilization, principles of operation and indications for use to current commercially available catheters/cited predicates.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol is a stylized representation of a caduceus, a staff with two snakes entwined around it, which is a symbol of medicine and healing. The seal is used to represent the HHS and its mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 8 2007

Ms. Lynn M. Kirchoff Regulatory Affairs Specialist Bard Access Systems, Incorporated 5425 West Amelia Earhart Drive Salt Lake City, Utah 84116

Re: K070996

Trade/Device Name: 4 Fr Single Lumen (SL) PowerPICC® Catheter Regulation Number: 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: April 6, 2007 Received: April 9, 2007

Dear Ms. Kirchoff:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898, In addition, FDA may publish further announcements concerning your device in the Federal Register.

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## Page 2 - Ms. Kirchoff

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K570YY6
4 Fr SL PowerPICC®
Special 510(k)

## Section 1.2

# Indications for Use Statement

5 10(k) Number (if known):

Device Name: 4 Fr Single Lumen (SL) PowerPICC® Catheter

Indications For Use:

The PowerPICC® catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, power injection of contrast media and allows for central venous pressure monitoring. For blood sampling, infusion or therapy, use a 4 French or larger catheter. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aitken V. Vartan

of Anesthesiology, General Hospital, Jon Control, Dental Dovices

Number: K970496

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